FDA Approves Roche Zika Virus Test for Blood Donation Screening

The U.S. Food and Drug Administration has approved Roche Molecular Systems’ cobas Zika test, the first commercially available test for the detection of the Zika virus RNA in samples of human plasma intended for use in screening blood donations.

The Zika virus is transmitted primarily by mosquitos (Aedes aegypti), but it can also be spread through blood transfusion and sexual contact. This approval marks an important milestone in the effort to protect the blood supply from Zika virus in the U.S. The newly approved cobas Zika test can now be used alongside other routine tests for the screening of blood and plasma donations in the United States.

“Screening blood donations for the Zika virus is critical to preventing infected donations from entering the U.S. blood supply,” noted Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, in a 5 Oct press release. “Today’s approval is the result of a commitment by the manufacturer to work rapidly and collaboratively with the FDA and the blood collection industry to respond to a public health crisis and ensure the safety of blood in the U.S. and its territories.”

In August 2016, the FDA issued a final guidance document recommending that all states and territories screen s with an investigational blood screening test available under an application, or a licensed (approved) test when available.

Before achieving FDA approavl, several blood collection establishments used the cobas Zika test under investigational new drug (IND) in order to follow the recommendations in the FDA’s August 2016 guidance document to screen individual units of whole blood and blood component for Zika virus.

The data collected from this testing, and from additional studies performed by the manufacturer, demonstrated that the cobas Zika test is an effective test to screen blood donors for Zika virus infection. The test’s clinical specificity was evaluated by testing individual samples from blood donations at five external laboratory sites, resulting in clinical specificity of more than 99 percent.

The Zika virus belongs to the Flaviviridae family of viruses, which includes dengue, yellow fever, Japanese encephalitis and West Nile viruses. Zika is mainly spread by the bite of infected mosquitoes; however, transmission through sexual intercourse and from pregnant mothers to fetuses has also been documented. Similar to other viruses in the Flaviviridae family, such as West Nile Virus, it is suspected that infected donor blood used for transfusions could serve as an additional transmission route for Zika virus.